Baricitinib yields sustained response over 68 weeks in atopic dermatitis

Continuous treatment with baricitinib maintains clear or almost clear skin in patients with moderate-to-severe atopic dermatitis (AD) over 68 weeks, according to long-term results from the BREEZE-AD3 study presented during EADV 2020.

Baricitinib is an oral selective inhibitor of Janus kinase (JAK) 1 and 2, which has previously been shown to improve AD symptoms in patients with moderate-to-severe disease in two, 16-week phase III double-blind studies, BREEZE-AD1 and BREEZE-AD2.

After 16 weeks, responders (defined by vIGA*-AD score of 0 or 1) and partial responders (vIGA-AD score of 2) of the two studies above continued receiving either baricitinib 2 mg or 4 mg once daily for another 52 weeks (total 68 weeks of continuous therapy) in the BREEZE-AD3 extension study.

After 68 weeks of continuous baricitinib, responder rate was maintained at 40 percent in the 4 mg arm, compared with 45.7 percent at the start of BREEZE-AD3 (baseline) — indicating that nearly half of patients had sustained “clear or almost clear skin”.   

Similarly, the proportion of responders remained stable through 68 weeks for the 2-mg baricitinib group, at 50 percent compared with 46.3 percent at baseline.

Also, response for disease severity — as indicated by a 75-percent improvement on the Eczema Area and Severity Index (EASI-75) — was maintained from baseline with continuous therapy for both the 4-mg arm (from 70.0 percent to 51.4 percent) and the 2-mg arm (from 74.1 percent to 64.8 percent).

“The results demonstrate that baricitinib’s efficacy at achieving clear or almost clear skin could be sustained with continuous treatment,” said presenting author Dr Jonathan Silverberg from The George Washington University School of Medicine and Health Sciences in Washington DC, US. “These data support its potential use as a treatment for adults with moderate to severe AD.”

In addition, patients also saw sustained treatment effects through 32 weeks of continuous baricitinib therapy on patient-reported outcomes such as itch, skin pain, and sleep disturbance due to itch.

Specifically, treatment effects on itch (indicated by ≥4-point improvement in the Itch Numeric Rating Scale [NRS]) were maintained through 32 weeks with both the 4-mg dose (at 41.0 percent from 52.2 percent) as well as the 2-mg dose (at 32.6 percent from 44.2 percent).

At week 32, the proportion of patients achieving ≥1.5-point improvement in the score of the Atopic Dermatitis Sleep Scale (ADSS) Item 2 also persisted from 75.0 percent at baseline to 71.4 percent in the 4-mg arm and from 73.7 percent to 68.4 percent in the 2-mg arm.

Furthermore, the response rate with regard to skin pain remained mostly stable throughout, from 61.8 percent to 49.1 percent in the 4-mg arm and from 47.5 percent to 37.5 percent in the 2-mg arm.

There were no new safety concerns with continuous therapy in the extension study, which showed a safety profile consistent with the initial 16-week placebo-controlled phase of the study, Silverberg reported.

*vIGA: validated Investigator Global Assessment score